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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Details as Recorded in OASIS by FDA

for Refusal 442-0717182-6/1/1

Manufacturer FEI3007119796
Manufacturer NameFujian Galle Commodity Co., Ltd  
Manufacturer Address line 1Xingtai Industril Park, Changtai  
Manufacturer Address line 2  
Manufacturer's CityZhangzhou  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code53JY01  
Importer's Product DescriptionSOAP /ST#JO-IND01 /COLOR: PINK,VANILLA SANDALWOOD /PO#22273  
Refusal Date12-Dec-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx 442-0717182-6/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis Yes  
Violation Code Section Charge Statement
COSM COLOR   601(e), 801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).